“In recent years, drug development in pain therapy has been focused mainly on reformulations of existing therapies and alternative modes of drug delivery to improve the delivery, safety, and efficacy of existing drug groups,” Holmes says.
For example, in March, Endo Pharmaceuticals acquired the Johnson Matthey patent for oxymorphone hydrochloride, extending patent protection for Endo’s entire oxymorphone franchise through 2029, including its new crush-proof tablets. Other drug developers are extending their brands through new indications. A look at Pfizer’s pipeline reveals 14 pain therapies in development, of which five are for new indications or enhancements.
Opioid analgesics form the largest single category of drugs in development, with a focus on formulations designed to reduce the risk of abuse. “Despite safety concerns, opioids remain the mainstay of moderate-to-severe pain therapy so it’s no surprise that several companies are developing potentially safer products,” Holmes says.
As the current market leaders go off patents, generic competition will become increasingly relevant. “The growth in the generic market is largely the result of the looming patent cliff,” Holmes says. “There already are tentative approvals from the FDA for generic versions of major sellers like Lyrica (pregabalin) and Cymbalta (duloxetine).
“A U.S. District Court has issued an order that prohibits the sale of generic duloxetine prior to patent expiry in June 2013, but it’s likely the generic market for this drug will be hotly contested,” she says. “We know of eight companies with tentative FDA approval for their generic versions of this product to date, and there are ongoing patent infringement actions with respect to Lyrica, which is currently patented in the U.S. to 2018.”
One strategy, Holmes says, is OTC switching—re-launching a former blockbuster for OTC use. When Novartis did this with Voltaren® (diclofenac) in 1999, the prescription brand continued strong sales in emerging markets because the brand was trusted, yet OTC sales hit $791 million in 2010.
“Generic drug makers are sitting pretty now,” Steuart says. A 2011 Supreme Court ruling effectively exempts generic manufacturers from liability, reasoning that under the Hatch Waxman Act (which authorized generics) they have no control over the information on their labels. “That eliminates a huge liability for generics manufacturers.”